OBJECTIVE:To further perfect our Pharmaceutical Administration Law of PRC.METHODS:Contractive methods were used to analyze comparatively the legal liabilities in US FDCA and Pharmaceutical Administration Law of PRC with regard to awarding system for reporters,penalty terms and the disposition of the confiscated drugs.RESULTS&CON?CLUSION:Compared with the PRC Pharmaceutical Administration Law,the US FDCA is more comprehensive and more consummate.We should follow the legislative spirit in FDCA and take it as a reference to improve our Pharmaceutical Ad?ministration Law.

OBJECTIVE:To provide references for the establishment of drug recall system in China.METHODS: The drug recall system in U.S.A. was introduced so as to get some enlightenment for the drug safety in China.RESULTS & CONCLUSION: We could use the drug recall system in U.S.A. for references to improve our law criterion system and carry out drug recall system on a large scale.

Objective:To establish an HPLC method for the simultaneous determination of 7 flavonoids in Fengliaochangweikang capsules, and optimize the extraction process for total flavones. Methods:The extraction process was optimized by orthogonal test. The analysis was performed on a Waters RP18 column (250 mm × 4. 6 mm,5 μm). The mobile phase A was methanol-water (80 :20) and the mobile phase B was methanol-0. 2% formic acid (17 :83) with gradient elution. The flow rate was 1. 0 ml·min-1 and the column temperature was 35℃. The detection wavelength changed as follows:0-27 min,λ1 = 260 nm;27-60min,λ2 = 360 nm. Results:The 7 flavonoids obtained the baseline separation in 60 min, and the linear correlation coefficients were all above or equal to 0. 9900. The average recovery was 95. 95%-97. 84% and RSD was 0. 81%-1. 33%. The optimum extraction conditions were as follows:solid-liquid ratio was 1 :15,AB-8 macroporous adsorption resin was used, the ultrasonic extraction time was 30min, and the ethanol concentration was 60%. Conclusion:The established method has the advantages of simple operation, high precision and good repeatability,which shows certain guiding significance for the quality control and detection of Fengliaochangweikang capsules.

Renal function is closely associated with the risk of mortality ,cardiovascular events ,and progression to end stage of renal disease for patients with chronic kidney disease ( CKD ).Equations for estimated glomerular filtration rate ( GFR) based on serum creatinine or Cystatin C are frequently used in clinical evaluation of renal function.Although renal function can be more accurately assessed due to improvement in equations for estimated GFR ,it is difficult to overcome the inherent defect of creatinine based GFR estimation.Abundant ,evidence showed that Cystatin C based GFR estimation presented higher accuracy of prognosis assessment in CKD patients than creatinine based GFR estimation ,thus reduce the unnecessary nephrologist referral and measurements for low risk patients ,and also guarantee the timely recognization and intervention for high risk patients.This article deeply reviewed the role of serum creatinine or Cystatin C played in CKD diagnosis and prognosis assessment.

Objective:To explore the chemical-biological evaluation pattern for the quality control and evaluation of Chinese materia medica solid preparations( CMMSP) according with the characteristics of Chinese traditional medicines. Methods:Lonicera granule as the model drug, the bacteria sensitive tests [minimal inhibitory concentration (MIC) and minimal bactericidal concentration(MBC)] were applied to study the antimicrobial effect of Lonicera extract on 4 kinds of standard strains ( Staphylococcus aureus, Streptococcus pneumoni-ae, Escherichia coli and Pseudomonas aeruginosa). The standard curves of the relationship between the anti-bacterial ring diameter for sensitive bacterial and the concentration of Lonicera extracts were established, and the biological potency of Lonicera granule from differ-ent manufacturers was calculated and compared with the result of the HPLC method ( measured by chlorogenic acid) . Results:The anti-microbial test showed that Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli and Pseudomonas aeruginosa were susceptible to Lonicera, and the antibacterial circle edge for Staphylococcus aureus was clear with higher sensitivity. There was a good linear relation-ship between the logarithmic dose and the response effect when the concentration of Lonicera was within the range of 0. 014 2-0. 068 0 g· ml-1(r=0.990 9). Conclusion:As a quality control method for Lonicera and Lonicera granules, the bioassay is feasible, which can ef-fectively cooperate with the traditional test method for the quality control of Lonicera and its preparations.

The current situation of subject service and the needs of users for subject service in 4 class A Beijing hospital libraries were investigated with questionnaires. The inadequacies of information service in hospital libraries were summarized and measures for its improvement were put forward.

Objective To establish a method of preparing metoprolol succinate sustained-release tablet and its content determination. Methods The formulation was optimized through the orthogonal design test by using release rate of the drug as an indicator.The different batches of metoprolol succinate sustained-release tablets were determined by HPLC. Results The tablets could release drug steadily and slowly as designed,which was similar to imported tablets. The linear range of metoprolol succinate was 10-70 μg?mL-1( r=0.999 8) . Conclusion The releasing rate of metoprolol succinate sustained-release tablet prepared in optimum condition can meet the requirement. This preparation technology is simple, the assay method is rapid, sensitive and reproducible.

Objective Nanomedicine is a branch of nanotechnology; it applies scientific principles and established methods of nanotechnology in healthcare. Small sized nanoparticles exhibit unique material properties. Nanoparticle therapeutic agents can be delivered with minimal invasiveness in vivo,and react more specifically to target tissues.Breast cancer is the most common cancer among women.Its incidence increases every year globally.Conventional therapeutic methods for breast cancer are effective,but have many limitations.In recent years the rapid development of nanotechnology medicine provides new solutions for those problems.There are many types of nanoengineered drug delivery systems (nDDS),each with distinguishing properties, including organic and inorganic materials, for example liposomes, polymers, antibodies, metals, magnets, carbons and ceramics. Nanomedicine may have passive and active targeting strategies. Both can enhance the accumulation of the drug in tumor sites. Specific nanoparticles can also kill or damage tumor cells.As its research advances fast,a wide application of nanomedicine in treating breast cancer is getting adopted.Many agents and formulations of nanomedicine are approved for clinical trials or approved for prescription.

A simple and accurate method is described for the quantitative determination of acid phosphatase in macrophage, spleen and thymus homogenates, utilizing sodium ?-naphthyl acid phosphate as substrate, and the monocoupler Fast Red B Salt as the color developer to measure ?-naphthol released from the substrate by enzymatic hydrolysis reaction.The color product is a deep blue azo dye,stable for at least 1h in alkaline condition. The method is sensitive enough for assay of enzyme activity of macrophages at concentration low as 1?10~6 cell/ml. The acid phosphatase activity of macrophages from mice treated with thioglycollate elevated significantly. Some factors affecting assay are discussed. Above all, the color developer solution should be made freshly and the peritoneal macrophages collected from mice should be broken in an ultrasonic breaker before assay.

OBJECTIVE: To discuss the limitation of the current TRIPS due to local protection and to seek for a balance between drug patent protection and public health.METHODS: The related clauses in TRIPS in terms of protection on drug patent and public health were introduced,and Nordhaus' model was used to analyze the conflict between drug patent protection and public health.RESULTS: The area with minimum level of drug patent protection can't be enlarged infinitely geographically.CONCLUSIONS: Preferential policies should be given to the developing countries to secure the public health while strengthening the drug patent protection gradually.